Mary Lynne Hedley, PhD
The FDA granted niraparib’s new drug application a priority review in December based on the phase 3 ENGOT-OV16/NOVA trial, where niraparib, when used as a maintenance therapy, reduced the risk of progression or death by 73 percent compared with placebo in patients who had germline BRCA-positive, platinum-sensitive, recurrent ovarian cancer. The median progression-free survival (PFS) after 16.9 months was 21 months with niraparib, compared with 5.5 months in patients treated with a placebo.
Expanded access programs offer patients who may not otherwise qualify for clinical trials access to investigational medicines. These patients typically have serious illnesses and are at a loss for alternate therapies.
“The niraparib EAP will provide a mechanism by which eligible women with ovarian cancer may benefit from access to this investigation therapy, which has been accepted for priority review by the U.S. FDA,” Mary Lynne Hedley, PhD, president and TESARO’s chief operating officer, said in a statement.
Other ongoing studies of niraparib include the phase 3 PRIMA trial for women who have received first-line treatment for ovarian cancer, the phase 2 QUADRA trial for women with ovarian cancer who have received multiple lines of therapy, and the phase 3 BRAVO trial, for patients with germline BRCA-mutated, metastatic breast cancer. Niraparib is also being investigated in combination studies investigating the agent in combination with other therapies, such as Keytruda (pembrolizumab) and Avastin (bevacizumab).
Patients interested in enrolling in the US EAP should first speak with their health care providers to determine if niraparib is a viable treatment option for them. Then, they can call Idis Managed Access at 1-877-768-4303 or email niraparibUSEAP@clinigengroup.com.